Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 8:46 PM
Study NCT ID:
NCT03824704
Status:
TERMINATED
Last Update Posted:
2023-06-12
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Sponsor:
pharmaand GmbH
Organization:
Study Overview
Official Title:
A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor made a business decision to discontinue the study due to low accrual.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer.
Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab:
* Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
* Cohort A2: BRCA mutation in tumor
Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab:
* Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
* Cohort A2: BRCA mutation in tumor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: